The PrEliMS Feasibility Trial

NCT03735056 | Completed DMC

• 1 other identifier: 18053
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The PrEliMS study is a mixed-methods feasibility randomised controlled trial of a point of diagnosis intervention programme which aims to provide emotional support for newly diagnosed people with Multiple Sclerosis (MS). This feasibility study will enable us to plan for a definitive trial to evaluate the clinical and cost-effectiveness of this point of diagnosis intervention programme. The aim is to assess the feasibility of the trial procedures and intervention, and to evaluate the key feasibility parameters before proceeding to a definitive trial. Participants (N=60) will be randomised into three groups: (1) usual care; (2) usual care + Support 1 (MS Nurse Support); (2) usual care + Support 2 (MS Nurse Support plus Peer Support).

Conditions

Multiple Sclerosis

Keywords

Diagnosis; Emotional support; Peer support

Outcome Measures

Primary Outcomes (15)

• Feasibility of trial procedures

  \[Note: As feasibility studies are used to estimate important parameters to inform the design of a full trial (NIHR, 2018), we outline the key outcomes related to feasibility. These are described below. Please see Outcome 1-15.\] Feasibility of trial procedures will be assessed through feedback interview (qualitative) data from participants and service providers (i.e., questions about the research process/procedures, and suggested changes to the study).

  Daily throughout data collection

• Acceptability of trial procedures

  Assessed through feedback interview (qualitative) data from participants and service providers on the trial procedures.

  Daily throughout data collection

• Feasibility of randomisation protocol

  Assessed through feedback interview (qualitative) data on randomisation protocol and willingness and acceptance of patients to be randomised.

  Daily throughout data collection

• Feasibility of recruitment

  Number of those eligible who expressed interest/discussed with researcher, number of consenting/randomised patients, reasons for non-participation, retention rates, feedback interview (qualitative) data.

  Daily throughout data collection

• Estimating sample size needed for a Phase III RCT

  Sample size calculated through effect sizes from ANOVAs, standard deviations and attrition rates.

  Daily throughout data collection

• Appropriateness of measures

  Completion rates of outcome measures, number of missing online and postal data, estimates of time (minutes) taken to complete measures (from online/phone data or feedback interview data).

  Daily throughout data collection

• Feasibility of self-report data collection

  Number of missing online and postal data

  Daily throughout data collection

• Feasibility of audio recording support sessions

  Number of participants consenting to audio recording of sessions and feedback interview data

  Daily throughout data collection

• Acceptability of interventions (Support 1 and Support 2)

  Drop-out rates (and reasons for withdrawal), number of Support 1 and Support 2 sessions completed, feedback interview data.

  Daily throughout intervention delivery

• Feasibility of delivering Support 1 intervention

  Number of missed and rescheduled sessions, length of sessions (minutes), operational issues in delivering intervention through feedback interview data.

  Daily throughout intervention delivery

• Feasibility of delivering Support 2 intervention

  Number of missed and rescheduled sessions, length of sessions (minutes), operational issues in delivering intervention through feedback interview data.

  Daily throughout intervention delivery

• Credibility of interventions

  Assessed through qualitative feedback interview data (i.e., questions about the content of the intervention, changes experienced).

  Daily throughout data collection

• Fidelity of intervention

  Fidelity rating on audio data from a sample of support sessions against criteria for PrEliMS model consistency.

  Daily throughout intervention delivery

• Documentation of usual care

  Data obtained through service use questionnaire and feedback interviews.

  Daily throughout data collection

• Feasibility of collecting data for an economic evaluation using a bespoke service use questionnaire

  Number of missing or clearly invalid service use questionnaire data, completion rates, exploration of possible ceiling effects, feedback interview (qualitative) data.

  Daily throughout data collection

Other Outcomes (6)

• Perceived stress

  Baseline, 3-month follow-up, and 6-month follow-up

• Mood

  Baseline, 3-month follow-up, and 6-month follow-up

• Psychological impact of MS

  Baseline, 3-month follow-up, and 6-month follow-up

Study Arms (3)

Group 1 (Usual care)

NO INTERVENTION

Receives usual care only.

Group 2 (Usual care plus Support 1)

EXPERIMENTAL

Receives usual care plus Support 1 (MS Nurse Support) which includes one one-to-one, face-to-face session with an MS Nurse Specialist in a hospital setting (or via Skype). The session will include answering newly diagnosed patients' questions about MS, providing psychoeducation and teaching Acceptance and Commitment strategies (Hayes, Strosahl \& Wilson, 1999), and referring to other services (based on needs). Participants will also be given a self-help workbook ('Better living with a diagnosis of MS: Patient Workbook') by the nurses. This session will take place within 2 weeks of diagnosis and last up to 90 minutes. It will be supplemented by phone calls (depending on participant needs). MS Nurses will receive training and on-going supervision from experienced clinical psychologists.

Other: MS Nurse Support

Group 3 (Usual care plus Support 2)

EXPERIMENTAL

Receives usual care plus Support 2 (i.e. MS Nurse Support plus Peer Support). In addition to receiving the MS Nurse Support (i.e. Support 1, as described in Group 2), this group will also receive peer support which will be provided by Peer Support Workers who are patients/carers with lived experience and who are recruited and trained to deliver peer support under supervision from experienced clinical psychologists. It will be delivered one-to-one, face-to-face (in a community setting or via Skype, based on participants' preferences). Patients in this group will be triaged to a Peer Support Worker by the MS Nurse during the 2-week MS Nurse Support session. The sessions will be scheduled to a convenient time between weeks 2-6 after diagnosis and each session will last up to 60 minutes.

Other: MS Nurse Support; Other: Peer Support

Interventions

MS Nurse Support OTHER

MS Nurse Support intervention is multi-faceted, involving various components (i.e. information provision and emotional support), and a range of strategies and techniques (e.g. psychoeducation, acceptance and commitment), delivered by MS Nurse Specialists, to provide standardised support and advice to patients at diagnosis, to establish and sustain coping strategies. MS Nurse Support intervention is person-centred and tailored to the needs and lifestyle of each participant.

Group 2 (Usual care plus Support 1); Group 3 (Usual care plus Support 2)

Peer Support OTHER

Peer Support will be delivered by Peer Support Workers using information provision and supportive listening to provide support and advice to patients at diagnosis, and to provide patients the opportunity to talk freely, extensively and confidentially about their experiences, thoughts and feelings about MS diagnosis and its effects on their lives in a non-judgmental and safe environment. Peer Support intervention is person-centred and tailored to the needs and lifestyle of each participant.

Group 3 (Usual care plus Support 2)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients will be eligible to join the trial if they:
• are 18 years or over
• have recently received a diagnosis of MS (any type of MS) or currently going through MS diagnosis process)
• can communicate in English
• able and willing to give consent
• not receiving psychological intervention

You may not qualify if:

• Patients will be excluded if they:
• have a severe co-morbid psychiatric condition (e.g. dementia), as reported by patients or their carers or confirmed by the clinical team making the initial approach
• are currently receiving psychological interventions or received this within the last three months (we will not exclude those on medication for their mood problems but will record this information).
• do not have mental capacity to consent to take part in the trial
• are unable to communicate in English

Sponsors & Collaborators

• University of Nottingham: lead
• Multiple Sclerosis Society UK: collaborator
• Swansea University: collaborator

Study Sites (1)

Nottingham University Hospitals NHS Trust

Nottingham, United Kingdom

Location

MeSH Terms

Conditions

Multiple Sclerosis; Disease

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Roshan das Nair, PhD

  University of Nottingham

  PRINCIPAL INVESTIGATOR

• Gogem Topcu, PhD

  University of Nottingham

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2018
• First Posted: November 8, 2018
• Study Start: November 30, 2018
• Primary Completion: October 31, 2020
• Study Completion: October 31, 2020
• Last Updated: November 9, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)